Intraocular irrigator-aspirator tip component

ABSTRACT

An ophthalmic irrigator-aspirator has a handpiece with aspiration and irrigation openings through its distal end. A tip component connects to the handpiece and has an aspiration cannula. A flexible sleeve has an annular hub for watertight connection to the handpiece or a base portion of the tip. The sleeve has an intermediate portion that forms a channel for an irrigation fluid along the exterior of the cannula to an irrigation port in the sleeve. The distal end portion of the sleeve is sized for a watertight connection over the distal portion of the cannula. Such distal end portion of the sleeve has an aspiration port in communication with the cannula aspiration port. The sleeve proximate, intermediate, and distal portions are integral with each other and are formed of a resilient material that allows the sleeve to be tightly fitted on the handpiece or tip base portion and the cannula.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a continuation of patent application Ser. No.14/559,649, filed Dec. 3, 2014, which is a continuation of patentapplication Ser. No. 14/046,777, filed Oct. 4, 2013, which claims thebenefit of Provisional Application No. 61/759,560, filed Feb. 1, 2013,and Provisional Application No. 61/710,610, filed Oct. 5, 2012, thedisclosures of which are hereby expressly incorporated by referenceherein.

BACKGROUND

The present invention pertains to an improved irrigator-aspirator tipcomponent of the type inserted into the lens capsule of an eye, such asfor removing cortical material, washing, cleaning and/or polishing.

SUMMARY

This summary is provided to introduce a selection of concepts in asimplified form that are further described below in the DetailedDescription. This summary is not intended to identify key features ofthe claimed subject matter, nor is it intended to be used as an aid indetermining the scope of the claimed subject matter.

In accordance with the present invention, a unitary, one-piece sleeve isprovided for an ophthalmic irrigator-aspirator instrument of the typehaving a handpiece with an aspiration opening through the distal endthereof and one or more irrigation openings adjacent to the aspirationopening. The instrument includes an elongated, narrow tip projectingfrom the handpiece distal end, such tip having an internal borecommunicating with the handpiece aspiration opening and an aspirationport at or adjacent to a distal end of the tip. The novel sleeve has aproximate annular hub portion constructed and arranged to be manuallyconnected to a distal end portion of the handpiece in a watertight fit,with the sleeve surrounding the tip. An intermediate portion of thesleeve forms a channel for an irrigation fluid between the exterior ofthe tip and the interior portion of the sleeve. The channel is incommunication with the handpiece irrigation opening and an irrigationport adjacent to the distal end of the sleeve, for conveying theirrigation fluid through the channel and ejecting it from the irrigationport of the sleeve. The distal end portion of the sleeve is sized forconnection over the distal portion of the tip in a watertight fit at alocation between the sleeve irrigation port and the aspiration port ofthe tip. Such distal end portion of the sleeve has an aspiration portlocated to be in communication with the tip aspiration port. The sleeveproximate, intermediate, and distal portions are integral with eachother and are formed of a resilient material that allows the sleeve tobe manually stretched onto the handpiece and tip.

DESCRIPTION OF THE DRAWINGS

The foregoing aspects and many of the attendant advantages of thisinvention will become more readily appreciated as the same become betterunderstood by reference to the following detailed description, whentaken in conjunction with the accompanying drawings, wherein:

FIG. 1 is a top front perspective of an intraocular irrigator-aspiratortip component in accordance with the present invention with parts shownin exploded relationship;

FIG. 2 is a corresponding perspective thereof on a somewhat larger scaleshowing some parts assembled;

FIG. 3 is a vertical axial section thereof with the parts shown in thepositions of FIG. 2;

FIG. 4 is a section corresponding to FIG. 3 but on a larger scale andwith parts fully assembled;

FIG. 4A is a further enlarged, fragmentary, vertical section of theintraocular irrigator-aspirator tip component of FIGS. 1-4;

FIG. 5 is a top front perspective of a second embodiment of anintraocular irrigator-aspirator tip component in accordance with thepresent invention with parts shown in exploded relationship;

FIG. 6 is a corresponding perspective thereof on a somewhat larger scaleshowing some parts assembled;

FIG. 7 is a vertical axial section thereof with the parts shown in thepositions of FIG. 6;

FIG. 8 is a section corresponding to FIG. 3 but on a larger scale andwith parts fully assembled;

FIG. 8A is a further enlarged, fragmentary, vertical section of theintraocular irrigator-aspirator tip component of FIGS. 5-8;

FIG. 9 is a top front perspective of a modified form of an intraocularirrigator-aspirator tip component in accordance with the presentinvention with parts shown in exploded relationship;

FIG. 10 is a fragmentary, enlarged, top plan thereof with the partsassembled;

FIG. 11 is a vertical axial section thereof with the parts shown in thepositions of FIG. 10;

FIG. 12 is a top front perspective of another modified form of anintraocular irrigator-aspirator tip component in accordance with thepresent invention with parts shown in exploded relationship;

FIG. 13 is a corresponding perspective thereof on a somewhat largerscale showing some parts assembled;

FIG. 14 is a vertical axial section thereof with the parts shown in thepositions of FIG. 13;

FIG. 15 is a section corresponding to FIG. 14 but on a larger scale andwith parts fully assembled; and

FIG. 15A is a further enlarged, fragmentary, vertical section of theintraocular irrigator-aspirator tip component of FIGS. 12-15.

DETAILED DESCRIPTION

With reference to FIG. 1, an irrigation-aspiration handpiece 10 has adistal portion 12 adapted to receive a separate tip 14 which typicallyis surgical grade stainless steel or titanium. In a representativeembodiment, tip 14 is reusable and has an externally threaded proximatestem 16 for reception in the internally threaded bore 18 that opens atthe distal end of the handpiece. FIGS. 2-4 show the tip 14 after it hasbeen joined to the handpiece 10. In FIG. 3 it can be seen that the tip14 has an internal bore 17 that communicates with the centrallongitudinal bore 18 of the handpiece 10. At the proximate end, thehandpiece is connected to a low pressure or vacuum source, such thataspiration is achieved through the distal end port 20 of the tip 16 ascontrolled by the user (typically a surgeon). In addition, the handpiecehas an annular channel 22 for discharge of an irrigation liquid, such asto compensate for material aspirated through the tip 14.

In accordance with one embodiment of the present invention, a one-pieceor unitary sleeve 24 of a soft, resilient material, such as siliconerubber, is provided for fitting tightly over the tip 14 and the distalend portion of the handpiece 10 to which the tip has been joined.

With reference to FIG. 4, the resilient sleeve 24 has a distal hubportion 26 with a wall diameter somewhat greater than the remainder ofthe sleeve for increased rigidity adjacent to a lip 28 in the area wherethe sleeve would typically be grasped by the surgeon or technicianassembling the apparatus. At the proximate end, on the internal face 30,the sleeve is tapered for ease in fitting the sleeve on and over thedistal tip portion of the handpiece. The handpiece can be formed with anexternal thread 32 or a series of ribs to achieve a watertight fit ofthe sleeve on the handpiece.

The diameter of an intermediate portion of the sleeve 24 graduallydecreases along the length of the tip 14, being sized to form an annularchannel 34 which is in communication with the handpiece irrigationchannel 22. Moving still farther in a distal direction, the wallthickness of the sleeve lessens to increase the overall flexibility ofthe sleeve in the area where it will protrude through a cornealincision.

The details of the distal-most portion of the sleeve 24 and inner tip 14are best seen in FIG. 4A. In this embodiment, the distal end of the tip14 has the end port 20. The sleeve 24 has a distal end portion 36 thatprojects beyond the end port 20, with an internal aspiration cavity 38in communication therewith. In the embodiment shown, the end portion 36of the sleeve has an annular shoulder 40 to butt against the distal endof the tip 14 when the sleeve is inserted fully over the tip. Anexternal aspiration port 42 is formed in the distal sleeve part 36. Inthe illustrated embodiment, port 42 extends obliquely, which ispreferred, but it can be positioned at any desired location around thesleeve portion 36. The wall thickness at the distal portion 36 isgreater than the thickness where the sleeve fits over the tip 14, for asomewhat less flexible but still soft tip that can be manipulated by thesurgeon to a desired location. The fit of the sleeve around the distalend of the tip is very snug and watertight.

Still referring to FIG. 4A, one or more ports 44 are provided forexpulsion of irrigation liquid close to the aspiration port butnevertheless spaced proximate therefrom. As shown in the drawings, portor ports 44 are located along the distal portion of the tip between thelocation of a bend B and the aspiration port 20, and the sleeve has acorresponding bend B′ at the same location. Thus the distal end portionsof the aspiration tip and the sleeve are angled relative to the longer,straight, more proximate portion that extends back toward the handpiece.During an intraocular procedure both ports may be positioned inside thecornea and even inside the lens capsule. The distal part 36 of thesleeve is unsupported and should have sufficient rigidity that it doesnot collapse so as to block aspiration. Nevertheless, the part of thesleeve 24 proximate to the irrigation port 44 will be fitted through asmall corneal slit, and should be sufficiently flexible to conform tothe shape of the slit without unduly stretching or tearing the cornea.Whereas the tip 14 itself is very rigid and can have sharp edges thatcould tear delicate eye tissue with which they come into engagement, thesleeve is soft enough that the risk of tearing, cutting, or abrasion ofeye tissue is reduced significantly. In addition, the sleeve protectsthe tip 14 from being damaged, such as by contact with other instrumentsduring surgery.

FIGS. 5 to 8A correspond, respectively, to FIGS. 1 to 4A, but for asecond representative embodiment of the present invention. The handpiece10 is the same, including the distal portion 12, central aspiration bore18, and annular irrigation channel 22. The separate tip 14′ has the samethreaded stem 16 for joining to the handpiece, but the distal endportion of the tip 14′ and the distal end portion of the sleeve 24′ area little different.

As best seen in FIG. 8A, the distal end of the tip 14′ is closed, andthe aspiration port 20′ opens through the side, very close to the distalend. The distal end portion 36′ of the resilient sleeve tightly embracesthe closed end of the tip 14′ and the end portion on both sides of theport 20′ in a watertight fit. The sleeve 24′ has an aspiration port 42′located to register with the tip port 20′ when the parts are assembled.Port 42′ can be smaller than port 20′ so that the hard and potentiallysharp metal inner tip will not come in contact with delicate eye tissueduring use.

For both illustrated embodiments it is important that the sleeve 24/24′be fully inserted on the tip 14/14′, and for both embodiments it isimportant that the sleeve be correctly aligned or registered with thetip. FIGS. 9-11 illustrate modifications that can be used with bothembodiments to assist in obtaining the correct relative orientation. Thetip 14/14′ is “clocked” to the handpiece 10′ so that the relativeorientation will be the same each time one of the aspiration tips isconnected. For example, in FIG. 9 the bend B of the tip toward itsdistal end would always be oriented vertically upward. A registrationmark (arrow 50) is formed on the exterior of the handpiece forreference, preferably on an enlarged extension 52. Extension 52 has aflat annular face 54 from which the distal portion 12′ extends. Suchportion 12′ has a pair of longitudinally spaced, circumferential ribs32′ adjacent to the distal end of the handpiece. The sleeve 24″ also hasa registration mark (arrow 54) formed thereon. During assembly, thesurgeon or technical assistant can manually pull the sleeve over theaspirator tip 14/14′ while keeping the registration marks in alignment,thereby assuring the correct relative orientation.

In addition, the construction of the modified sleeve 24″ and handpiece10′ help assure that the sleeve will be fully stretched over the tip andhandpiece to the desired degree, and no more. The proximate end of thesleeve will abut against the face 54 of the handpiece extension 52, and,as seen in FIG. 11, an internal rib 56 of the sleeve 24″ is snuglyreceived between the handpiece ribs 32′ when the desired fit isachieved.

FIGS. 12 to 15A correspond, respectively, to FIGS. 1 to 4A, but for athird representative embodiment of the present invention. The handpiece10′ is the same as previously described except for the distal portion12″′. For example, the handpiece of the third embodiment still has thecentral aspiration bore 18 (see FIGS. 14 and 15) and annular irrigationchannel 22, and the bore and channel open through the distal end of thedistal portion 12″′. The outer periphery of the distal portion 12″′ isconfigured for connection to a composite rigid tip component 60. Tipcomponent 60 has an internally threaded hub or base 62 for joining tothe handpiece, such as by mating threads (external on the handpiecedistal portion 12″′ and internal in the hub or base 62). FIGS. 13, 14,and 15 show the hub or base 62 connected to the handpiece.

The hub or base 62 can be formed of a rigid plastic material. Thecomposite tip 60 includes a rigid (preferably surgical grade stainlesssteel or titanium) cannula 64 projecting distally from the hub or base62. The cannula is fixed in the base, such as by overmolding duringmanufacturing. As seen in FIG. 15, the bore 66 of the cannulacommunicates with the aspiration bore 18 of the handpiece and canterminate at or near a distal port 68.

As best seen in FIGS. 13 and 14, the hub or base 62 includes a distalprotrusion or stem 70. As seen in FIGS. 14 and 15, stem 70 haslongitudinal passages 72 that communicate with the annular irrigationchannel 20 of the handpiece.

This embodiment includes a thin-walled resilient sleeve 24″′ similar tothe sleeves previously described. The proximate end portion (hub) 74 ofsleeve 24″′ can be fitted tightly over the stem 70 of the composite tipcomponent 60. As best seen in FIG. 15, an interior rib 76 at theproximate end of the sleeve can be received in a groove 78 at theproximate end of the stem for a reliable connection of the sleeve to thestem. For registration purposes, the outer periphery of the stem can bea shape other than cylindrical and the proximate portion of the sleeveshaped the same. In the illustrated embodiment the stem and sleeve areapproximately triangular in transverse cross section so the sleeve willbe oriented correctly as it is slid on the stem prior to use of the IAinstrument.

As best seen in FIG. 15A, the distal end of the rigid cannula opensthrough an end port 68. The distal end portion of the resilient sleeve24″′ tightly embraces the tip of the cannula in a watertight fit. Thesleeve 24″′ has an aspiration port 80 in fluid communication with thebore of the cannula, and a nearby irrigation port 82 that communicateswith the annular passage for irrigation liquid that flows from thehandpiece, such port 82 being positioned between the aspiration end port68 and the bend B′ which overlies the tip bend B, although there can bean overlap of the proximate edge of the irrigation port with the distalpart of the tip bend B, as shown in FIG. 15A.

Although this embodiment shows an end port for the cannula, the cannulaand sleeve can be modified similar to the embodiment of FIGS. 6 to 8Afor a side port application. Either way, it is intended that thisembodiment of a composite tip and one-piece or unitary resilient sleevebe sold preassembled as a single use item for quick and reliableconnection to a reusable handpiece. Both aspiration and irrigation aresupported, and sterility is assured because the tip and sleeve arediscarded after one use.

While illustrative embodiments have been illustrated and described, itwill be appreciated that various changes can be made therein withoutdeparting from the spirit and scope of the invention.

The embodiments of the invention in which an exclusive property or privilege is claimed are defined as follows:
 1. An ophthalmic irrigator-aspirator instrument comprising: a handpiece with proximate and distal ends, the handpiece having an aspiration opening through the distal end thereof and one or more irrigation openings adjacent to the aspiration opening; a tip component having: a proximate base portion constructed and arranged to be manually connected to a distal end portion of the handpiece in a watertight fit and surrounding the aspiration and irrigation openings of the handpiece, the base portion having irrigation openings therethrough in communication with the handpiece irrigation openings; an elongated cannula having a proximate end portion joined to the base portion, a distal end portion, and a bend between the proximate and distal end portions and adjacent to a distal end of the cannula, the cannula having an internal bore communicating with the handpiece aspiration opening and an aspiration port at or adjacent to the distal end of the cannula spaced in a distal direction from the bend; and a sleeve component having: a proximate annular hub portion constructed and arranged to be manually connected to a distal end portion of the tip component base portion in a watertight fit; an intermediate portion surrounding the elongated tip of the instrument and forming an irrigation channel between the tip base portion and an interior portion of the sleeve which channel is in communication with the handpiece irrigation opening, the intermediate sleeve portion having a bend overlying the bend of the cannula, an irrigation port adjacent to a distal end of the sleeve and located at least partially distal to the bend of the elongated tip for ejection of an irrigation fluid therefrom; and a distal end portion sized for connection over a distal portion of the cannula in a watertight fit at a location distal of the sleeve irrigation port but proximate of the cannula aspiration port, the sleeve distal end portion having an aspiration port located to be in communication with the cannula aspiration port when the sleeve is stretched over the distal portion of the cannula, the sleeve proximate, intermediate, and distal portions being integral with each other and formed of a resilient material that allows the sleeve to be stretched onto the handpiece and tip. 